Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction

Prognosis Clinical Trial

— ELC-CHN  

Official title:

Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02618681
• Other study ID #: JQi
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2015
• Last updated: December 7, 2015
• Start date: June 2015
• Est. completion date: June 2019

Study information

• Verified date: December 2015
• Source: Liaoning University of Traditional Chinese Medicine
• Contact: Jing Qi, Master
• Email: saraok[@]126.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine
• Study type: Observational

Clinical Trial Summary

To investigate the feasibility of the earlobe crease as an early prognostic predictor for acute myocardial infarction(AMI) in Chinese population.

Description:

Primary Objective : 1 year primary composite end point (including the whole death, recurrent myocardial infarction, stroke, target vessel revascularization, stent thrombosis) in AMI patients with different types of earlobe crease.

Secondary objective:

1. The incidence of complications during hospitalization

2. The rate of rehospitalization due to cardiovascular disease

3. The incidence of revascularization at 1 year after AMI

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 902
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Initial acute myocardial infarction(AMI)

2. Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin (cTn) with at least one value above the 99th percentile upper reference limit (URL)) and with at least one of the following:

• Symptoms of ischemia

• Development of pathologic Q waves in the electrocardiogram (ECG)

• New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).

• Identification of an intracoronary thrombus by angiography or autopsy

• Imaging evidence of new loss of viable myocardium or a new regional wall motion abnormality.

3. Type 1 (spontaneous myocardial infarction(MI)) in the third universal definition of MI: MI consequent to a pathologic process in the wall of the coronary artery (eg, plaque erosion/rupture, fissuring, or dissection), resulting in intraluminal thrombus.

4. Infarct related artery (IRA) showed that acute thrombus formation, IRA occlusion or stenosis =95%?=90%~95%?=90%,thrombolysis in myocardial infarction (TIMI)0-3 flow.

5. PCI(percutaneous coronary intervention)intervention(PCI for STEMI within 12 hours after symptom onset).

6. Signed informed consent.

Exclusion Criteria:

1. Combined valvular heart disease, cardiomyopathy, blood diseases, skin diseases, rheumatic diseases, ischemic cerebrovascular disease, tumor, etc.

2. Previous myocardial infarction.

3. Previous PCI and coronary artery bypass graft(CABG).

4. Chronic total occlusion(CTO)lesions.

5. Ear malformation.

6. Ocular diseases.

7. Participating in a clinical study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ear Abnormalities
• Infarction
• Myocardial Infarction
• Prognosis

Locations

Country	Name	City	State
China	Jing	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Jing Qi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary composite end point (including the whole death, recurrent myocardial infarction, stroke, target vessel revascularization, stent thrombosis) in AMI patients with different types of earlobe crease.		1 year	Yes